Enhanced method for the determination of an analyte concentration in body fluid

Abstract

A method for determining analyte concentration in a body fluid using a mobile device having a camera and a lidar sensor that have an overlapping field of view. In the method, an object is selected and the user is prompted to apply a body fluid sample to a reagent test region. The user is prompted to provide the object within the overlapping field of view of the camera and the lidar sensor. The processor of the mobile device generates a lidar measurement data set representing the object, which is compared to a pre-generated data set. When there is a degree of congruence from the comparison that is above a pre-determined minimum, the camera captures an image of the reagent test region having the body fluid sample applied thereto and concentration of analyte in the sample is determined. When the congruence is below a pre-determined minimum, image capturing is not allowed.

What is claimed is: 
     
         1 . An analytical method for determining analyte concentration in a body fluid using a mobile device having a camera and a lidar sensor that have an at least partially overlapping field of view, the method comprising:
 a) providing an object selected from the group consisting of: an optical test element having a reagent test region, a color reference card having a reagent test region, a color reference card adapted to be associated with an optical test element having a reagent test region adapted for application of a sample of the body fluid, and wherein the reagent test region is adapted to undergo, at least partially, a color formation reaction when the sample of the body fluid is applied thereto;   b1) prompting, by the display, a user to apply a drop of the body fluid to the reagent test region and/or prompting, by the display, a user to confirm application of a drop of the body fluid to the reagent test region;   b2) prompting, by a display of the mobile device, the user to provide the object within the at least partially overlapping field of view of the camera and the lidar sensor;   c) generating, by the processor, a lidar measurement data set at least for the object by receiving output data from the lidar sensor, the lidar measurement data set representing a three-dimensional structure of at least a part of the object;   d) comparing, by a processor of the mobile device, the lidar measurement data set from step c) to a pre-generated lidar data set for the object that represents a three-dimensional structure of the entire object, thereby obtaining an item of information on a degree of congruence of the lidar measurement data set and the pre-generated lidar data set; and   e1) when the item of information from step d) indicates a degree of congruence equal to or above a pre-determined minimum degree of congruence: capturing, by the camera, a measurement image of at least a part of the reagent test region having the sample of the body fluid applied thereto, and determining the concentration of the analyte in the body fluid based at least on the measurement image captured; or   e2) when the item of information from step d) indicates a degree of congruence below a pre-determined minimum degree of congruence:
 at least temporarily not allowing the capturing by the camera of a measurement image of at least a part of the reagent test region having the sample of the body fluid applied thereto; and/or 
 indicating by the display a warning to the user; and/or 
 indicating by the display instructions to the user to take an appropriate action in order to capture, by the at least one camera, a measurement image of at least a part of the reagent test region having the sample of the body fluid applied thereto. 
   
     
     
         2 . The method according to  claim 1 , further comprising, after step a) and before step b1), a step b2′), corresponding to step b2); and a step c′), corresponding to step c); and a step d′), corresponding to step d); wherein, if the item of information from step d′) indicates a degree of congruence above a pre-determined minimum degree of congruence, the method further comprises capturing, by the at least one camera, an initial image of at least a part of the reagent test region without having the sample of the body fluid applied thereto. 
     
     
         3 . The method according to  claim 2 , further comprising, in step e1), taking the initial image into account for the determining of the concentration of the analyte in the body fluid. 
     
     
         4 . The method according to  claim 2 , further comprising, after step b1) and before steps e1) or e2), a step of waiting a predetermined minimum amount of time. 
     
     
         5 . The method according to  claim 1 , further comprising, in step c), identifying, by the processor, in the lidar measurement data set at least two segments, wherein at least one of the segments identified is a segment containing foreground elements, and wherein at least another one of the segments identified is a segment containing background elements, relative to one another. 
     
     
         6 . The method according to  claim 1 , further comprising, in step d), for the comparing of the lidar measurement data set from step c) to a pre-generated lidar data set for the object: superimposing, by the processor, the lidar measurement data set from step c) with corresponding image data received from the at least one camera, thereby obtaining a combined measurement data set; and using the combined measurement data set as the lidar measurement data set for the comparing in step d). 
     
     
         7 . The method according to  claim 6 , further comprising, for the superimposing by the processor, selecting the lidar measurement data set from step c) and the corresponding image data received from the camera, whereby the data relating to essentially the same point in time is superimposed. 
     
     
         8 . The method according to  claim 5 , further comprising, in step c) and/or in step d), applying, by the processor, one or more image processing techniques to the lidar measurement data set, to the image data received from the at least one camera, to the combined measurement data set, and/or to a part of any of the foregoing. 
     
     
         9 . The method according to  claim 5 , further comprising: detecting, by the processor, the object, in the lidar measurement data set from step c), in a segment containing background elements; and detecting, by the processor, at least a partial overlap of a foreground element with at least a part of the object. 
     
     
         10 . The method according to  claim 1 , wherein, when the item of information from step d) is selected from a group consisting of a low degree of congruence and a high degree of congruence, the pre-determined minimum degree of congruence is set as high; or wherein, when the item of information from step d) is selected from a group consisting of a low degree of congruence, a medium degree of congruence, and a high degree of congruence, the pre-determined minimum degree of congruence is set as medium or as high; or wherein, when the item of information from step d) is selected to represent the degree of congruence as a percentage value, then the required pre-determined minimum degree of congruence is set to a level of congruence of at least 50%. 
     
     
         11 . The method according to  claim 1 , wherein, in step e2), the appropriate action to be taken by the user is at least one of: clearing the overlapping field of view, at least in between the camera and the at least one object, of any obstacles; moving the mobile device in at least one direction, relative to the at least one object; and changing an angle of orientation of the mobile device relative to the at least one object; such that the overlapping field of view, at least in between the camera and the at least one object, is clear of any obstacles. 
     
     
         12 . A mobile device having a camera, a lidar sensor, a processor, and a display, wherein the camera and the lidar sensor have an at least partially overlapping field of view, the mobile device being configured for determining a concentration of an analyte in a body fluid by capturing at least one image of at least a part of (i) an optical test element having a reagent test region, (ii) a color reference card associated with such an optical test element having a reagent test region, or (iii) a color reference card having a reagent test region, by using the camera, and by determining the at least one analyte concentration from a color formation reaction at the reagent test region, wherein the mobile device further is configured for performing at least steps b1), b2), c), d), e1) and e2) of the analytical method according to  claim 1 . 
     
     
         13 . A kit, comprising a mobile device according to  claim 12 , and at least one object selected from the group consisting of: an optical test element having a reagent test region, a color reference card having a reagent test region, a color reference card adapted to be associated with an optical test element having a reagent test region; wherein the reagent test region is adapted for application of a sample of a body fluid, and wherein the reagent test region is adapted to undergo, at least partially, a color formation reaction when the sample of the body fluid is applied to the reagent test region. 
     
     
         14 . A non-transitory computer-readable medium having stored thereon computer-executable instructions for performing the method according to  claim 1 . 
     
     
         15 . A method for determining analyte concentration in a body fluid using a mobile device having a camera and a lidar sensor that have an overlapping field of view, the method comprising:
 selecting an optical test element having a reagent test region and prompting the user to apply a body fluid sample to the reagent test region;   prompting the user to provide the object within the overlapping field of view of the camera and the lidar sensor;   generating with the processor a lidar measurement data set representing the object, which is compared to a pre-generated data set;   wherein, when there is a degree of congruence resulting from the comparison that is above a pre-determined minimum, the camera captures an image of the reagent test region having the body fluid sample applied thereto and concentration of analyte in the sample is determined; and   further wherein, when the congruence resulting from the comparison is below a pre-determined minimum, image capturing is not permitted.